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General Principals Of Software Validation
Here are the key definitions and terminology related to software validation: 3.1.1 Requirements and Specifications Requirements define what the software should do. Specifications define how the software will meet the requirements. Requirements and specifications should be documented, agreed upon, controlled and traceable. 3.1.2 Verification and Validation Verification ensures the software meets specifications. Validation ensures the software meets the intended use and user needs. Both are required to confirm the software functions as intended and is safe for clinical use. 3.1.3 IQ/OQ/PQ IQ (Installation Qualification) confirms the software system is installed correctly. OQ (Operational Qualification) confirms the software system operates
